Actively Recruiting
Alzheimer's Disease and Faecal Microbiota Transplantation Pilot Study
Led by University Hospital of North Norway · Updated on 2026-04-22
10
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
U
University Hospital of North Norway
Lead Sponsor
U
UiT The Arctic University of Norway
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the feasibility and safety of faecal microbiota transplantation (FMT) for people with Alzheimer's disease (AD), which is the most common cause of dementia. This study explores the possible link between gut flora and the development or progression of AD, based on evidence that gut flora differs between people with AD and healthy individuals. The study is sponsored by the University Hospital of North Norway and is a phase 1 trial. Participants will receive a preprocessed stool solution from a healthy donor via colonoscopy, where the solution is administered to the right side of the colon. This single-group, open-label study involves one intervention arm using FMT. The procedure is given once during a colonoscopy examination. During the study, participants will be monitored from baseline through 3 months after the FMT procedure. Researchers will assess safety by tracking treatment-related adverse events and feasibility by measuring recruitment rates, colonoscopy completion, and study completion. Cognitive function will be evaluated using various tests like the Clinical Dementia Rating Scale and Montreal Cognitive Assessment. Quality of life and daily living activities will also be assessed to understand the impact of the treatment.
CONDITIONS
Brief Title
Alzheimer's Disease and Faecal Microbiota Transplantation -a Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Alzheimer's dementia mild to moderate stage
- Presence of Alzheimer pathology core 1 biomarkers as defined by National Institute on Aging-Alzheimer's Association (NIA-AA) criteria (2024)
- Capable of giving informed consent
You will not qualify if you...
- Contraindications for colonoscopy examination
- Contraindications for Magnetic Resonance Imaging (MRI)
- Life expectancy less than 1 year
- Clinical frailty scale 7 or more
- History of seizure disorder
- History of brain tumour or intracranial bleed
- Major psychiatric disorder such as schizophrenia, bipolar disorder, or major depressive disorder
- Alcohol or substance abuse
- Decompensated heart disease
- Malignancy
- Current use of anticoagulant treatment (dual acting oral anticoagulant or warfarin)
- Pregnant or planning pregnancy
- Colonic adenomas over 1 cm, tumours or signs of active colitis on colonoscopy
- Status after colectomy or hemicolectomy
- Inflammatory bowel disease
- Immunocompromised individual
- Receiving biological/antibody treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single intervention day
Participants receive faecal microbiota transplantation administered via colonoscopy to the right side of the colon.
1 colonoscopy visit (in-person)
Duration - 3 months after faecal microbiota transplantation
Participants are monitored for safety and undergo cognitive assessments after treatment.
1 visit at 3 months (in-person)
Trial Site Locations
Total: 1 location
1
University Hospital of North Norway, Tromsø
Tromsø, Troms, Norway, 9016
Actively Recruiting
Research Team
M
Mona Dixon Gundersen, MBChB, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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